116 HR 3947 IH: Competition Prescription Act of 2019
U.S. House of Representatives
2019-07-24
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.Short title; table of contents
(a)This Act may be cited as the Competition Prescription Act of 2019
. (b)The table of contents for this Act is as follows:
Sec. 1. Short title; table of contents.
Title I—ELIMINATING DELAYS OF GENERIC DRUGS AND BIOSIMILAR PRODUCTS
Sec. 101. Actions for delays of generic drugs and biosimilar biological products.
Sec. 102. REMS approval process for subsequent filers.
Title II—INCREASING ACCESS TO DRUGS AND BIOSIMILAR PRODUCTS
Sec. 201. Expedited development and priority review for generic complex drug products.
Sec. 202. Increasing pharmaceutical options to treat an unmet medical need.
Sec. 203. Preemption of State barriers to the substitution of biosimilar products.
Sec. 204. Expedited process for biological products authorized for marketing in European Union.
Title III—PRESCRIPTION DRUG PRICING AND COMPETITION
Sec. 301. Medicare drug coverage.
Sec. 302. Fee transparency between pharmacies and PBMs.
Sec. 303. Sunset of limit on maximum rebate amount for single source drugs and innovator multiple
source drugs.
Sec. 304. Regulation of manufacturer-sponsored copay contributions.
Title IV—PATENT DISCLOSURE REQUIREMENTS
Sec. 401. Patent disclosure and transparency requirements.
Sec. 402. Antitrust exemption for health insurance issuers to negotiate wholesale acquisition
prices of prescription drugs purchased from drug manufacturers.
Sec. 403. Fair treatment of Medicare part B billing codes for the prescribing of biosimilars.
Title V—FIXING GLOBAL FREELOADING
Sec. 501. Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative.
<enum>I</enum><header>ELIMINATING DELAYS OF GENERIC DRUGS AND BIOSIMILAR PRODUCTS</header>
<section id="HE347B4C6456D4DAAB1F41C9709494266"><enum>101.</enum><header>Actions for delays of generic drugs and biosimilar biological products</header>
<subsection id="HC1BD8EC37D3848C78A90311A3266C46F"><enum>(a)</enum><header>Definitions</header><text>In this section—</text> <paragraph id="H3FC68D3C28E24F7E8379C89F94D9D9FC"><enum>(1)</enum><text>the term <term>commercially reasonable, market-based terms</term> means—</text>
<subparagraph id="HDB30E30F319E462DA053424D2AB920CE"><enum>(A)</enum><text>a nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug, as defined in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B));</text>
</subparagraph><subparagraph id="HB98AEFAEC812445584F1E795D49C7B81"><enum>(B)</enum><text>a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection (b)(2)(A)(iv); and</text>
</subparagraph><subparagraph id="H75496A82D26B46FB91B01580586462E8"><enum>(C)</enum><text>no additional conditions are imposed on the sale of the covered product;</text> </subparagraph></paragraph><paragraph id="H750964C7B1FD4EE2A295CD339DBBBF93"><enum>(2)</enum><text>the term <term>covered product</term>—</text>
<subparagraph id="H5B4771A115FE4AC59F31CF1F86AC878B"><enum>(A)</enum><text>means—</text> <clause id="H200CFB221EE04EA0AD84262EF5906295"><enum>(i)</enum><text>any drug approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) or biological product licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>);</text>
</clause><clause id="H6F156B7176814A88B0CFDCF0280CBC84"><enum>(ii)</enum><text>any combination of a drug or biological product described in clause (i); or</text> </clause><clause id="H5A0227AF378648EA8F4EC79CC32D13FC"><enum>(iii)</enum><text>when reasonably necessary to support approval of an application under section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>), or section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>), as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and</text>
</clause></subparagraph><subparagraph id="H73427C6F464E486A992C9D5CA5F16878"><enum>(B)</enum><text display-inline="yes-display-inline">does not include any drug or biological product that appears on the drug shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356e">21 U.S.C. 356e</external-xref>), unless—</text>
<clause id="H4C75141DC3384CBFA86ADB058382FD5F"><enum>(i)</enum><text display-inline="yes-display-inline">the drug or biological product has been on the drug shortage list in effect under such section 506E continuously for more than 6 months; or</text>
</clause><clause id="H0992CADCB8A7430091034A734BAAE38C"><enum>(ii)</enum><text display-inline="yes-display-inline">the Secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage;</text>
</clause></subparagraph></paragraph><paragraph id="H9257E4550AA44DCB80DF3F6A28EFC4B7"><enum>(3)</enum><text>the term <term>device</term> has the meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>);</text>
</paragraph><paragraph id="H51B06A0B1E344363923E64B5BC44B718"><enum>(4)</enum><text>the term <term>eligible product developer</term> means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) or for licensing pursuant to an application under section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>);</text>
</paragraph><paragraph id="H9A6797C7A0174BE1BC50FF9740CECA16"><enum>(5)</enum><text>the term <term>license holder</term> means the holder of an application approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) or the holder of a license under subsection (a) or (k) of section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) for a covered product;</text>
</paragraph><paragraph id="H54DA2C918EF74F42A5559E7A9C88F02D"><enum>(6)</enum><text>the term <term>REMS</term> means a risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1</external-xref>);</text>
</paragraph><paragraph id="HCA6DE92F0F6D454495C62D489CD54134"><enum>(7)</enum><text>the term <term>REMS with ETASU</term> means a REMS that contains elements to assure safe use under section 505–1(f) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1(f)</external-xref>);</text>
</paragraph><paragraph id="HC5ED5D94BE50460DA13AE617DBB049B7"><enum>(8)</enum><text>the term <term>Secretary</term> means the Secretary of Health and Human Services;</text> </paragraph><paragraph id="HC337FE5866284E558D4FC1498E34C5B3"><enum>(9)</enum><text>the term <term>single, shared system of elements to assure safe use</term> means a single, shared system of elements to assure safe use under section 505–1(f) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1(f)</external-xref>); and</text>
</paragraph><paragraph id="H1B1DE3274069466CB8A7224896EEE14C"><enum>(10)</enum><text display-inline="yes-display-inline">the term <term>sufficient quantities</term> means an amount of a covered product that the eligible product developer determines allows it to—</text> <subparagraph id="HD1645B5A96744D3689629F72227FD014"><enum>(A)</enum><text>conduct testing to support an application under—</text>
<clause id="HB675DDE8DA624D069B6A46740A3EF06B"><enum>(i)</enum><text>subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>); or</text>
</clause><clause id="H7C6495C6A19F42A9A5B0BAE8A1AE94DE"><enum>(ii)</enum><text>section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>); and</text> </clause></subparagraph><subparagraph id="H5D7CBD155ACE4BF59E498F269D523B63"><enum>(B)</enum><text>fulfill any regulatory requirements relating to approval of such an application.</text>
</subparagraph></paragraph></subsection><subsection id="H19C93064B394449B8CED04403F4AE631"><enum>(b)</enum><header>Civil action for failure To provide sufficient quantities of a covered product</header>
<paragraph id="H416D8D54449548DCB8A4811E922BD983"><enum>(1)</enum><header>In general</header><text>An eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the United States alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable, market-based terms.</text>
</paragraph><paragraph id="H44E594681D5C4FDCA4A76357000F483F"><enum>(2)</enum><header>Elements</header>
<subparagraph id="HE11B1551B31441DB87E83BA4AD406358"><enum>(A)</enum><header>In general</header><text>To prevail in a civil action brought under paragraph (1), an eligible product developer shall prove, by a preponderance of the evidence—</text>
<clause id="HF79E0F9D3275478C9DAAAD75C0A85952"><enum>(i)</enum><text>that—</text> <subclause id="H57F37B9C0C1740AEA77BE9487702F67C"><enum>(I)</enum><text>the covered product is not subject to a REMS with ETASU; or</text>
</subclause><subclause id="H8BE5579225774F0F86372953689ED81C"><enum>(II)</enum><text>if the covered product is subject to a REMS with ETASU—</text> <item id="HE7E441CE44E34F80A4B7AC642581DBB1"><enum>(aa)</enum><text>the eligible product developer has obtained a covered product authorization from the Secretary in accordance with subparagraph (B); and</text>
</item><item id="H01C67CB7DC22451B9D5BEA431912D4BD"><enum>(bb)</enum><text>the eligible product developer has provided a copy of the covered product authorization to the license holder;</text>
</item></subclause></clause><clause id="H47895ADD73054D90BA240B7792D2FF00"><enum>(ii)</enum><text>that, as of the date on which the civil action is filed, the product developer has not obtained sufficient quantities of the covered product on commercially reasonable, market-based terms;</text>
</clause><clause id="H2C07991089514C58A648E78246DB8F15"><enum>(iii)</enum><text>that the eligible product developer has requested to purchase sufficient quantities of the covered product from the license holder; and</text>
</clause><clause id="HAD6EF541631D45ACAA8C6662697E3844"><enum>(iv)</enum><text>that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable, market-based terms—</text>
<subclause id="H2EAB191FE2BA4E108C1753A20C122990"><enum>(I)</enum><text>for a covered product that is not subject to a REMS with ETASU, by the date that is 31 days after the date on which the license holder received the request for the covered product; and</text>
</subclause><subclause id="H9444D655610F4DF1A8F1F911479EC080"><enum>(II)</enum><text>for a covered product that is subject to a REMS with ETASU, by 31 days after the later of—</text> <item id="H7BD5EBC13D9D495EBDF2A6C1CE2B3759"><enum>(aa)</enum><text>the date on which the license holder received the request for the covered product; or</text>
</item><item id="H8F69614E2A294185A7225905D5E4A2BE"><enum>(bb)</enum><text>the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with subparagraph (B).</text>
</item></subclause></clause></subparagraph><subparagraph id="HBD642BC48FFF49A580AFDB039B025D9F"><enum>(B)</enum><header>Authorization for covered product subject to a REMS with ETASU</header>
<clause id="H52FF6A126DDC416291245F4DB9FA1442"><enum>(i)</enum><header>Request</header><text>An eligible product developer may submit to the Secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU.</text>
</clause><clause id="HE5BEC7166B4546B7AB17AF2295D0AE3E"><enum>(ii)</enum><header>Authorization</header><text>Not later than 120 days after the date on which a request under clause (i) is received, the Secretary shall, by written notice, authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU for purposes of—</text>
<subclause id="H1D9F3F630FD7499F8A4BED3F46D479E4"><enum>(I)</enum><text>development and testing that does not involve human clinical trials, if the eligible product developer has agreed to comply with any conditions the Secretary determines necessary; or</text>
</subclause><subclause id="H5FCA1C20ED5C477E8FBAAE6F1FFA01FE"><enum>(II)</enum><text>development and testing that involves human clinical trials, if the eligible product developer has—</text> <item id="H7304A4DE540B42CBBC3CA7500397E696"><enum>(aa)</enum> <subitem commented="no" display-inline="yes-display-inline" id="H73421AB6E1A148EE962805E9EA41BB99"><enum>(AA)</enum><text>submitted protocols, informed consent documents, and informational materials for testing that include protections that provide safety protections comparable to those provided by the REMS for the covered product; or</text>
</subitem><subitem id="HE51E5352FCD44EFEA36128B011C97FCC" indent="up1"><enum>(BB)</enum><text>otherwise satisfied the Secretary that such protections will be provided; and</text> </subitem></item><item id="H6C98A7447BF24E5A85D18EAF83CC23FB"><enum>(bb)</enum><text>met any other requirements the Secretary may establish.</text>
</item></subclause></clause><clause id="H7B5F8E3C04FD484AB8157D4D4C2CDF19"><enum>(iii)</enum><header>Notice</header><text>A covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the REMS for the covered product.</text>
</clause></subparagraph></paragraph><paragraph id="HCB3AE8391EB44A53A88C9CF491E2AE77"><enum>(3)</enum><header>Affirmative defense</header><text>In a civil action brought under paragraph (1), it shall be an affirmative defense, on which the defendant has the burden of persuasion by a preponderance of the evidence—</text>
<subparagraph id="H127EB18396CC4821A236C3865A37FBE9"><enum>(A)</enum><text>that, on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder—</text>
<clause id="HB47C221A2C5441E08E5A263685584BB4"><enum>(i)</enum><text>neither the license holder nor any of its agents, wholesalers, or distributors was engaged in the manufacturing or commercial marketing of the covered product; and</text>
</clause><clause id="H1ED18EB4FEC2496685A5D799911D85C8"><enum>(ii)</enum><text>neither the license holder nor any of its agents, wholesalers, or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable, market-based terms;</text>
</clause></subparagraph><subparagraph id="H94E2823D01B24816BAFB43898BE27E51"><enum>(B)</enum><text>that—</text> <clause id="H230F60C03C984659B453C50EFC0C4546"><enum>(i)</enum><text>the license holder sells the covered product through agents, distributors, or wholesalers;</text>
</clause><clause id="H8A650AC09A4D4153BA7A4C7E747ED234"><enum>(ii)</enum><text>the license holder has placed no restrictions, explicit or implicit, on its agents, distributors, or wholesalers to sell covered products to eligible product developers; and</text>
</clause><clause id="HC02CE879E2384A3F86A565F8212711CC"><enum>(iii)</enum><text>the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder; or</text>
</clause></subparagraph><subparagraph id="HF4DC92B0D4A34A048F9C5CD8400961A8"><enum>(C)</enum><text display-inline="yes-display-inline">that the license holder made an offer to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms—</text>
<clause id="HC5F9517BDF444ABABEEEFE96A3ECF773"><enum>(i)</enum><text>for a covered product that is not subject to a REMS with ETASU, by the date that is 14 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 7 days after the date on which the eligible product developer received such offer from the license holder; or</text>
</clause><clause id="H12C9AB86EDCC41A78339E65C6FC0C5CF"><enum>(ii)</enum><text>for a covered product that is subject to a REMS with ETASU, by the date that is 20 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 10 days after the date on which the eligible product developer received such offer from the license holder.</text>
</clause></subparagraph></paragraph><paragraph id="H642DF1321760470D94087B81EB333492"><enum>(4)</enum><header>Methods for transmission of requests for covered products</header><text display-inline="yes-display-inline">A written request for a covered product, offer to sell a covered product, or acceptance of such an offer between the eligible product developer and the license holder shall be made by—</text>
<subparagraph id="H918025B54BEE45CB81F583E1C40C50DD"><enum>(A)</enum><text>certified or registered mail with return receipt requested;</text> </subparagraph><subparagraph id="H4C7C3AC67C5D46CD8530916C1AB0612F"><enum>(B)</enum><text>personal delivery; or</text>
</subparagraph><subparagraph id="H3ACE66060ACE43089FF72F1CD08A71B9"><enum>(C)</enum><text>electronic means.</text> </subparagraph></paragraph><paragraph id="H5135A18A2A4B4FF99F2D5E9689FE955F"><enum>(5)</enum><header>Remedies</header> <subparagraph id="H123E2E4930ED403486538FCACD965CC7"><enum>(A)</enum><header>In general</header><text>If an eligible product developer prevails in a civil action brought under paragraph (1), the court shall—</text>
<clause id="H1817E2590BC84708ABB6D24ADA0CE814"><enum>(i)</enum><text>order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable, market-based terms;</text>
</clause><clause id="H8BB2228EB8AA4BF3941008EDE2A17A7D"><enum>(ii)</enum><text>award to the eligible product developer reasonable attorney's fees and costs of the civil action; and</text>
</clause><clause id="H2DC84F101FDA47D682A6CF512CB5D0D4"><enum>(iii)</enum><text>award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable, market-based terms, if the court finds, by a preponderance of the evidence—</text>
<subclause id="HE62116D89516423285CEB5EC48750B4D"><enum>(I)</enum><text>that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification; or</text>
</subclause><subclause id="HB0F485F36E774B27BFD690C3E590E121"><enum>(II)</enum><text>that the license holder failed to comply with an order issued under clause (i).</text> </subclause></clause></subparagraph><subparagraph id="HFD981A6F39D74F0DB60B29E5A8398E28"><enum>(B)</enum><header>Maximum monetary amount</header><text>A monetary amount awarded under subparagraph (A)(iii) shall not be greater than the revenue that the license holder earned on the covered product during the period—</text>
<clause id="HA7336646EAFB4EE88E25AA51DA8FE333"><enum>(i)</enum><text>beginning on—</text> <subclause id="H80009AAE17144173BE24F7872D828645"><enum>(I)</enum><text>for a covered product that is not subject to a REMS with ETASU, the date that is 31 days after the date on which the license holder received the request; or</text>
</subclause><subclause id="H13F9927001AE464F96BAEBD47A5B19E9"><enum>(II)</enum><text>for a covered product that is subject to a REMS with ETASU, the date that is 31 days after the later of—</text>
<item id="HE76BBE546FF142AAB68E9887C4526A55"><enum>(aa)</enum><text>the date on which the license holder received the request; or</text> </item><item id="HDE8FA4DB4F8240068E5FEF5BE4306B48"><enum>(bb)</enum><text>the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with paragraph (2)(B); and</text>
</item></subclause></clause><clause id="HD31E4D3AAF884E609E939B8D5DB28266"><enum>(ii)</enum><text>ending on the date on which the eligible product developer received sufficient quantities of the covered product.</text>
</clause></subparagraph><subparagraph id="H74515FC19F554936AE0AE3199324189A"><enum>(C)</enum><header>Avoidance of delay</header><text>The court may issue an order under subparagraph (A)(i) before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause (ii) or (iii) of subparagraph (A), or the amount of any such award.</text>
</subparagraph></paragraph></subsection><subsection id="H5123693FCE7B40D6BD149B644995C102"><enum>(c)</enum><header>Limitation of liability</header><text>A license holder for a covered product shall not be liable for any claim under Federal, State, or local law arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section, including transportation, handling, use, or disposal of the covered product by the eligible product developer.</text>
</subsection><subsection id="H920F3758C0AB495B8897A9F5FDD45B6E"><enum>(d)</enum><header>No violation of REMS</header><text display-inline="yes-display-inline">Section 505–1 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1</external-xref>) is amended by adding at the end the following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="H3B560DE318024D3BB7BDA2B49CCB83FC" style="OLC">
<subsection id="H0B73456DC81B4227A0BB782951779ED6"><enum>(l)</enum><header>Provision of samples not a violation of strategy</header><text display-inline="yes-display-inline">The provision of samples of a covered product to an eligible product developer (as those terms are defined in section 2(a) of the <short-title>Creating and Restoring Equal Access to Equivalent Samples Act of 2019</short-title>) shall not be considered a violation of the requirements of any risk evaluation and mitigation strategy that may be in place under this section for such drug.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H338C5A9B3E4A42619F780CB980325DDB"><enum>(e)</enum><header>Rule of construction</header>
<paragraph id="HBBAD41B589DD43B09E8D5880B1BCF92F"><enum>(1)</enum><header>Definition</header><text>In this subsection, the term <term>antitrust laws</term>—</text> <subparagraph id="HA3D0C379BC1E4D69BED10A70929556C3"><enum>(A)</enum><text>has the meaning given the term in subsection (a) of the first section of the Clayton Act (<external-xref legal-doc="usc" parsable-cite="usc/15/12">15 U.S.C. 12</external-xref>); and</text>
</subparagraph><subparagraph id="H822737A258654F1C9D20FB946BADCB92"><enum>(B)</enum><text>includes section 5 of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45</external-xref>) to the extent that such section applies to unfair methods of competition.</text>
</subparagraph></paragraph><paragraph id="H01ACB9A71C55447F946158DE68CE61AE"><enum>(2)</enum><header>Antitrust laws</header><text>Nothing in this section shall be construed to limit the operation of any provision of the antitrust laws.</text>
</paragraph></subsection></section><section id="HA43131E7A9654F68A2C843D2425D7F24"><enum>102.</enum><header>REMS approval process for subsequent filers</header><text display-inline="no-display-inline">Section 505–1 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1</external-xref>), as amended by section 101, is further amended—</text>
<paragraph id="H0C4D513574A445E088D5D2ACB0A464FE"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (g)(4)(B)—</text> <subparagraph id="HF40E65B2C84244B8BFD71CE60EFA91AF"><enum>(A)</enum><text display-inline="yes-display-inline">in clause (i) by striking <quote>or</quote> after the semicolon;</text>
</subparagraph><subparagraph id="H552341743E4944429E64CB7004241ABA"><enum>(B)</enum><text>in clause (ii) by striking the period at the end and inserting <quote>; or</quote>; and</text> </subparagraph><subparagraph id="HBBE5DA7B343D417F8C32F32A6AE56E02"><enum>(C)</enum><text>by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H81E9B25A8EFB47BC950DC3FE4C75A593" style="OLC">
<clause commented="no" id="HF7ABB8FCCE534ADD9545BCEFD1E9FBD1"><enum>(iii)</enum><text display-inline="yes-display-inline">accommodate different, comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section 505(j), and the applicable listed drug.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="H21114F809D0D4ECE846016F6C2744407"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (i)(1), by striking subparagraph (C) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H8AFDB374C36346E1BE84053C613DD758" style="OLC"> <subparagraph id="H44F55C3093134382811028D23872CD9E"><enum>(C)</enum> <clause commented="no" display-inline="yes-display-inline" id="HCC010DF0036F47D69E03F5B8D8A72597"><enum>(i)</enum><text>Elements to assure safe use, if required under subsection (f) for the listed drug, which, subject to clause (ii), for a drug that is the subject of an application under section 505(j) may use—</text>
<subclause id="HFA0E4E12DCAB44B985CA7DFB250457C1" indent="up1"><enum>(I)</enum><text>a single, shared system with the listed drug under subsection (f); or</text> </subclause><subclause id="H2A8E236F064144189E3311A1986E31F6" indent="up1"><enum>(II)</enum><text>a different, comparable aspect of the elements to assure safe use under subsection (f).</text>
</subclause></clause><clause id="HD6A87D9BE55A4AEA8CF9400470071317" indent="up1"><enum>(ii)</enum><text>The Secretary may require a drug that is the subject of an application under section 505(j) and the listed drug to use a single, shared system under subsection (f), if the Secretary determines that no different, comparable aspect of the elements to assure safe use could satisfy the requirements of subsection (f).</text></clause></subparagraph><after-quoted-block>; </after-quoted-block></quoted-block>
</paragraph><paragraph id="HA390F9EFED454319BA1284FDF9F22440"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (i), by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H666CDF27F7B842B5BC1F180326EBC728" style="OLC"> <paragraph id="H49F91CF82505471BA998E3E91729DF93"><enum>(3)</enum><header>Shared REMS</header><text display-inline="yes-display-inline">If the Secretary approves, in accordance with paragraph (1)(C)(i)(II), a different, comparable aspect of the elements to assure safe use under subsection (f) for a drug that is the subject of an abbreviated new drug application under section 505(j), the Secretary may require that such different comparable aspect of the elements to assure safe use can be used with respect to any other drug that is the subject of an application under section 505(j) or 505(b) that references the same listed drug.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block>
</paragraph><paragraph id="H5EF5155001CE455C851573626CE1C54E"><enum>(4)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HD638C381A22F49C6A83B380EA7658EF5" style="OLC"> <subsection id="H772413B6DDC247D49BEF75774F115DAD"><enum>(m)</enum><header>Separate REMS</header><text>When used in this section, the terms <term>different, comparable aspect of the elements to assure safe use</term> or <term>different, comparable approved risk evaluation and mitigation strategies</term> means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section 505(j) that uses different methods or operational means than the strategy required under subsection (a) for the applicable listed drug, or other application under section 505(j) with the same such listed drug, but achieves the same level of safety as such strategy.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><enum>II</enum><header>INCREASING ACCESS TO DRUGS AND BIOSIMILAR PRODUCTS </header>
<section id="HD6EA17189D034E91AA23747123FBE93E" section-type="subsequent-section"><enum>201.</enum><header>Expedited development and priority review for generic complex drug products</header><text display-inline="no-display-inline">Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351</external-xref> et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HE8FAAA27AD8D4FD5BA723A9191BDD2A3" style="OLC">
<section id="HFCF50D472C7F49DB99AA02F128322C6A"><enum>524B.</enum><header>Expedited development and priority review for generic complex drug products</header>
<subsection id="H821309EDBE5C47D0A8B27E6AA304250D"><enum>(a)</enum><header>Establishment of program</header><text display-inline="yes-display-inline">The Secretary shall establish a program to expedite the development of, and provide priority review under section 505(j) for, generic complex drug products.<italic></italic></text>
</subsection><subsection id="HE7E58D563D4949E58A3843A8608536E6"><enum>(b)</enum><header>Request for designation</header><text display-inline="yes-display-inline">A sponsor of a generic complex drug product may request that the Secretary designate such product for expedited development and priority review under this section.</text>
</subsection><subsection id="HB9D6AD18336349B68339C2718A80CA0A"><enum>(c)</enum><header>Designation process</header>
<paragraph id="HE02F1F66834B4420B44F41865D18732A"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 60 calendar days after the receipt of a request under subsection (c), the Secretary shall determine whether the product that is the subject of the request meets the criteria under subsection (e) to be considered a generic complex drug product. If the Secretary determines that the product meets the criteria, the Secretary shall designate the product for expedited development and priority review.</text>
</paragraph><paragraph id="H95C65653C1144EE2808D68D3113FB3C8"><enum>(2)</enum><header>Review</header><text>Review of a request under subsection (b) shall be undertaken by a team that is composed of experienced staff and senior managers of the Food and Drug Administration.</text>
</paragraph><paragraph id="H0EF376FA6A8040ABAB131CC19E7A8D05"><enum>(3)</enum><header>Withdrawal</header><text display-inline="yes-display-inline">The Secretary may not withdraw a designation granted under this section on the basis of the criteria under subsection (e) no longer applying because of the subsequent clearance or approval of any other product.<italic></italic></text>
</paragraph></subsection><subsection id="HA731E038A7FB42A8A8844069DE199E31"><enum>(d)</enum><header>Expedited development and priority review Guidance</header>
<paragraph id="HA875358F18CD41A1B72415C4CFD5536D"><enum>(1)</enum><header>Content</header><text display-inline="yes-display-inline"><italic></italic>Not later than December 31, 2021, the Secretary shall issue guidance on the implementation of this section. Such guidance shall—</text>
<subparagraph id="H2DBFE580411E40E0ACD35C38B5122813"><enum>(A)</enum><text>set forth the process by which a person may seek a designation under subsection (c);</text> </subparagraph><subparagraph id="HB8EC4A772EC54AB2ABBCC176B874518E"><enum>(B)</enum><text>provide a template for requests under subsection (b);</text>
</subparagraph><subparagraph id="H801EB15800124D78AF630D90E8DCBFA0"><enum>(C)</enum><text>identify the criteria the Secretary will use in evaluating a request for designation under this section; and</text>
</subparagraph><subparagraph id="HE5E25191A33345AB89244D30750973C8"><enum>(D)</enum><text>identify the criteria and processes the Secretary will use to expedite the development and review of products designated under this section.</text>
</subparagraph></paragraph><paragraph id="H39C82C069B33476489B38C6D0C1CAC4E"><enum>(2)</enum><header>Process</header><text>Prior to finalizing the guidance under paragraph (1), the Secretary shall seek public comment on a draft version of that guidance.</text>
</paragraph></subsection><subsection id="HC56D710895A7476FBBADB83AB18ADFE6"><enum>(e)</enum><header>Generic complex drug product defined</header><text>In this section, the term <term>generic complex drug product</term> means a product that represents a complex therapy that consists of or includes a drug for approval under section 505(j) and that—</text>
<paragraph id="HA15174B3C5044E8CAC1C2F154C1D8D98"><enum>(1)</enum>
<subparagraph commented="no" display-inline="yes-display-inline" id="H19D3B4E1F14346E8A88B1F0363BC6996"><enum>(A)</enum><text>contains complex active ingredients (such as peptides, polymeric compounds, complex mixtures of active ingredients, and naturally sourced ingredients);</text>
</subparagraph><subparagraph id="H36AE6731B4EB4F4385C1516788E767E0" indent="up1"><enum>(B)</enum><text>is composed of complex formulations (such as liposomes or colloids);</text> </subparagraph><subparagraph id="H680E1B967D0949D8A6CA2538EEC4ECA1" indent="up1"><enum>(C)</enum><text>requires a complex route of delivery (such as locally acting drugs such as dermatological products and complex ophthalmological products and otic dosage forms that are formulated as suspensions, emulsions, or gels); or</text>
</subparagraph><subparagraph id="H0815CDE761FA410388551057332A154E" indent="up1"><enum>(D)</enum><text>involves a complex dosage form (such as transdermals, metered dose inhalers, or extended release injectables);</text>
</subparagraph></paragraph><paragraph id="H4E42B58554C74CD99B0853347530740E"><enum>(2)</enum><text display-inline="yes-display-inline">presents as a complex drug-device combination product (such as auto injectors or metered dose inhalers); or</text>
</paragraph><paragraph id="H0AE5926714AD46E99B119DED286456D3"><enum>(3)</enum><text display-inline="yes-display-inline">is a product that would benefit from early scientific engagement due to complexity or uncertainty concerning the approval pathway under section 505(j).</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H0906DC777DB34D298B9377D5D9B96778"><enum>202.</enum><header>Increasing pharmaceutical options to treat an unmet medical need</header><text display-inline="no-display-inline">Subsection (b) of section 506 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356">21 U.S.C. 356</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H7DAB4661187643BBB2AB7F962C5B7040" style="OLC">
<paragraph id="HFEE6EB4038B243EE8394368E8184161E"><enum>(4)</enum><header>Unmet medical need</header><text display-inline="yes-display-inline">For purposes of paragraph (1), a drug shall be deemed to address an unmet medical need for a disease or condition if fewer than 3 available drugs exist for the treatment of such disease or condition.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H8652D83C632540C5BF679AA0386C532D"><enum>203.</enum><header>Preemption of State barriers to the substitution of biosimilar products</header><text display-inline="no-display-inline">No State, or any political subdivision thereof, may prohibit a pharmacy or pharmacist from dispensing, in place of a biological reference product, any product that, pursuant to section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>), has been determined by the Secretary of Health and Human Services to be interchangeable with the reference product in accordance with subsections (a) and (k)(4) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(a)</external-xref>, (k)(4)).</text>
</section><section id="H05AFECE3C2D3469CBA91DA64BE63A667"><enum>204.</enum><header>Expedited process for biological products authorized for marketing in European Union</header><text display-inline="no-display-inline">Section 351(a) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(a)</external-xref>) is amended by adding at the end the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="HC2481407723A4410A843E53B25C17D75" style="OLC">
<paragraph id="HF56ADE315DB94813B5F77D818FBEA486"><enum>(4)</enum><header>Products authorized for marketing in European Union</header><text display-inline="yes-display-inline">In considering whether to license a biological product under this subsection or subsection (k), the Secretary may expedite the licensing process if the biological product has been authorized for marketing by the European Medicines Agency and such authorization remains in effect.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>III</enum><header>PRESCRIPTION DRUG PRICING AND COMPETITION</header>
<section commented="no" id="HC982ABCB0ACD45C99E24C0A1C5E2E4F8"><enum>301.</enum><header>Medicare drug coverage</header><text display-inline="no-display-inline">Notwithstanding any other provision of law, the Secretary of Health and Human Services may alter payments for prescription drugs, including biologicals, provided through the Medicare part B program by paying at rates that, based on the average sales price plus 6 percent in the year of implementation of this Act, grow at the consumer price index (CPI Prescription Drugs).</text>
</section><section commented="no" id="H1EE5AF6F40854EEA838CA27CDD521330"><enum>302.</enum><header>Fee transparency between pharmacies and PBMs</header>
<subsection commented="no" id="HD4A6B32A46A840E59EBB2CD0A0FFAD2C"><enum>(a)</enum><header>Prohibiting medicare PDP sponsors and MA–PD organizations from retroactively reducing payment on
clean claims submitted by pharmacies</header>
<paragraph commented="no" id="H5F49E8F6982F437388CDE542180CC9F1"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1860D–12(b)(4)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)(4)(A)</external-xref>) is amended by adding at the end the following new clause:</text>
<quoted-block display-inline="no-display-inline" id="HE9352D40DD1B4421B88BAB3E6348D9C8" style="OLC">
<clause commented="no" id="HB1C97C309A9D4C60A93BCB5FF662A896"><enum>(iv)</enum><header>Prohibiting retroactive reductions in payments on clean claims</header><text display-inline="yes-display-inline">Each contract entered into with a PDP sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that after the date of receipt of a clean claim submitted by a pharmacy, the PDP sponsor (or an agent of the PDP sponsor) may not retroactively reduce payment on such claim directly or indirectly through aggregated effective rate or otherwise except in the case such claim is found to not be a clean claim (such as in the case of a claim lacking required substantiating documentation) during the course of a routine audit as permitted pursuant to written agreement between the PDP sponsor (or such an agent) and such pharmacy. The previous sentence shall not prohibit any retroactive increase in payment to a pharmacy pursuant to a written agreement between a PDP sponsor (or an agent of such sponsor) and such pharmacy.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="HDE1D5AAABE894CF4A2B1EB08B86E727E"><enum>(2)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendment made by subsection (a) shall apply with respect to contracts entered into on or after January 1, 2021.</text>
</paragraph></subsection><subsection commented="no" id="H7602010CD36E405DBF093F5C86B04720"><enum>(b)</enum><header>Elimination of DIR fees</header>
<paragraph commented="no" id="HA92758C1388B484EB5DD3254C4A73454"><enum>(1)</enum><header>Pharmacy benefits manager standards under the Medicare program for prescription drug plans and
MA–PD plans</header>
<subparagraph commented="no" id="H656C36FA79C241E984A129A53012A302"><enum>(A)</enum><header>In general</header><text>Section 1860D–12(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)</external-xref>) is amended by adding at the end the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="HCD2A710D88C44688813C6C6454E88975" style="OLC">
<paragraph commented="no" id="H18EEF3F483794C9097033A5B80FA1457"><enum>(7)</enum><header>Pharmacy benefits manager transparency requirements</header><text>Each contract entered into with a PDP sponsor under this part with respect to a prescription drug plan offered by such sponsor or with an MA organization offering an MA–PD plan under part C shall provide that the sponsor or organization, respectively, may not enter into a contract with any pharmacy benefits manager (referred to in this paragraph as a <quote>PBM</quote>) to manage the prescription drug coverage provided under such plan, or to control the costs of the prescription drug coverage under such plan, unless the PBM adheres to the following criteria when handling personally identifiable utilization and claims data or other sensitive patient data:</text>
<subparagraph commented="no" id="HC1F2464F4EC8448E989FDAF1B9DE1DB8"><enum>(A)</enum><text>The PBM may not transmit any personally identifiable utilization, protected health information, or claims data, with respect to a plan enrollee, to a pharmacy owned by a PBM if the plan enrollee has not voluntarily elected in writing or via secure electronic means to fill that particular prescription at the PBM-owned pharmacy.</text>
</subparagraph><subparagraph commented="no" id="H04142628C03A4C4AA5AEB853426DB5F4"><enum>(B)</enum><text>The PBM may not require that a plan enrollee use a retail pharmacy, mail order pharmacy, specialty pharmacy, or other pharmacy entity providing pharmacy services in which the PBM has an ownership interest or that has an ownership interest in the PBM, or provide an incentive to a plan enrollee to encourage the enrollee to use a retail pharmacy, mail order pharmacy, specialty pharmacy, or other pharmacy entity providing pharmacy services in which the PBM has an ownership interest or that has an ownership interest in the PBM, if the incentive is applicable only to such pharmacies.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" id="H12236B7301CA476D9E3EBB848F92CF1B"><enum>(B)</enum><header>Regular update of prescription drug pricing standard</header><text>Paragraph (6) of section 1860D–12(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)</external-xref>) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H28B4658EF8D542BBB6FC3F80E17B34A1" style="OLC">
<paragraph commented="no" id="H2A7626F82B7649F796D91DBFEB59FFCD"><enum>(6)</enum><header>Regular update of prescription drug pricing standard</header>
<subparagraph commented="no" id="H0DD4845D973F4386A8DA0E2F71910897"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">If the PDP sponsor of a prescription drug plan (or MA organization offering an MA–PD plan) uses a standard for reimbursement (as described in subparagraph (B)) of pharmacies based on the cost of a drug, each contract entered into with such sponsor under this part (or organization under part C) with respect to the plan shall provide that the sponsor (or organization) shall—</text>
<clause commented="no" id="HDDE811F2659740A9A70516ADD40E8B6D"><enum>(i)</enum><text>update such standard not less frequently than once every 7 days, beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug;</text>
</clause><clause commented="no" id="HD13B13AE955F44668D0CB4340DBF3F97"><enum>(ii)</enum><text>disclose to applicable pharmacies and the contracting entities of such pharmacies the sources used for making any such update immediately without requirement of request;</text>
</clause><clause commented="no" id="H24688B24EC7E4A84A4AB79EBEE195A3E"><enum>(iii)</enum><text display-inline="yes-display-inline">if the source for such a standard for reimbursement is not publicly available, disclose to the applicable pharmacies and the respective contracting entities of such pharmacies all individual drug prices to be so updated in advance of the use of such prices for the reimbursement of claims;</text>
</clause><clause commented="no" id="HC85D8F3736EC40E599D9B81A073EA65A"><enum>(iv)</enum><text display-inline="yes-display-inline">establish a process to appeal, investigate, and resolve disputes regarding individual drug prices that are less than the pharmacy acquisition price for such drug, which must be adjudicated within 7 days of the pharmacy filing its appeal; and</text>
</clause><clause commented="no" id="H77F4844907D647C0972829D767BE2E7F"><enum>(v)</enum><text display-inline="yes-display-inline">provide all such pricing data in an .xml spreadsheet format or a comparable easily accessible and complete spreadsheet format.</text>
</clause></subparagraph><subparagraph commented="no" id="H26B0A37C465946718DB0C0AD08A02002"><enum>(B)</enum><header>Prescription drug pricing standard defined</header><text display-inline="yes-display-inline">For purposes of subparagraph (A), a standard for reimbursement of a pharmacy is any methodology or formula for varying the pricing of a drug or drugs during the term of the pharmacy reimbursement contract that is based on the cost of the drug involved, including drug pricing references and amounts that are based upon average wholesale price, wholesale average cost, average manufacturer price, average sales price, maximum allowable cost (MAC), or other costs, whether publicly available or not.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" id="H510B3392A2784E578781346117DB508B"><enum>(C)</enum><header>Effective date</header><text>The amendments made by this section shall apply to plan years beginning on or after January 1, 2020.</text>
</subparagraph></paragraph><paragraph commented="no" id="H5DFEEC59319F4AEC86D56EBB78620CE3"><enum>(2)</enum><header>Regular update of prescription drug pricing standard under TRICARE retail pharmacy program</header><text>Section 1074g(d) of title 10, United States Code, is amended by adding at the end the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="H43D5A3FF7270454F9F9DE6CC9D31CB3C" style="USC">
<paragraph commented="no" id="HF5EF3A304FE444828EDC6EE16805494A" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">To the extent practicable, with respect to the TRICARE retail pharmacy program described in subsection (a)(2)(E)(ii), the Secretary shall ensure that a contract entered into with a TRICARE managed care support contractor includes requirements described in section 1860D–12(b)(6) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)(6)</external-xref>) to ensure the provision of information regarding the pricing standard for prescription drugs.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="H4D0FF1F79F9A41759CAD7B59105798DF"><enum>(3)</enum><header>Prescription drug transparency in the Federal Employees Health Benefits program</header>
<subparagraph commented="no" id="HF442ED63D5994E5ABDD20E42D575A418"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Section 8902 of title 5, United States Code, is amended by adding at the end the following new subsections:</text>
<quoted-block display-inline="no-display-inline" id="H154C6C4FBE2949ACB4DC2907CC885713" style="USC">
<subsection commented="no" id="H15AC17553BA14C5B9FB69E9DFC9CA1D1"><enum>(p)</enum><text display-inline="yes-display-inline">A contract may not be made or a plan approved under this chapter under which a carrier has an agreement with a pharmacy benefits manager (in this subsection referred to as a <quote>PBM</quote>) to manage prescription drug coverage or to control the costs of the prescription drug coverage unless the carrier and PBM adhere to the following criteria:</text>
<paragraph commented="no" id="HC445EA2AF1D74A179430CE0504DDF7E4"><enum>(1)</enum><text display-inline="yes-display-inline">The PBM may not transmit any personally identifiable utilization, protected health information, or claims data with respect to an individual enrolled under such contract or plan to a pharmacy owned by the PBM if the individual has not voluntarily elected in writing or via secure electronic means to fill that particular prescription at such a pharmacy.</text>
</paragraph><paragraph commented="no" id="H50400031D28E43F8BE28A9DE1C34F517"><enum>(2)</enum><text>The PBM may not require that an individual enrolled under such contract or plan use a retail pharmacy, mail order pharmacy, specialty pharmacy, or other pharmacy entity providing pharmacy services in which the PBM has an ownership interest or that has an ownership interest in the PBM or provide an incentive to a plan enrollee to encourage the enrollee to use a retail pharmacy, mail order pharmacy, specialty pharmacy, or other pharmacy entity providing pharmacy services in which the PBM has an ownership interest or that has an ownership interest in the PBM, if the incentive is applicable only to such pharmacies.</text>
</paragraph></subsection><subsection commented="no" id="HA1B90BF51A614DA28970048FD37549F0"><enum>(q)</enum>
<paragraph commented="no" display-inline="yes-display-inline" id="H1F1E85D4D2894ADC880DD5E0BDD915DD"><enum>(1)</enum><text>If a contract made or plan approved under this chapter provides for a standard for reimbursement (as described in paragraph (2)) with respect to a prescription drug plan, such contract or plan shall provide that the applicable carrier—</text>
<subparagraph commented="no" id="HB33DA20B2D95455EBB5F41CB714243FA" indent="up1"><enum>(A)</enum><text display-inline="yes-display-inline">update such standard not less frequently than once every 7 days, beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug;</text>
</subparagraph><subparagraph commented="no" id="H1814AB30FD674093A2CD92A13D2E7FA6" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">disclose to applicable pharmacies and the contracting entities of such pharmacies the sources used for making any such update immediately without requirement of request;</text>
</subparagraph><subparagraph commented="no" id="H6374DEA9CD50437FB0AC55C575C8CF9F" indent="up1"><enum>(C)</enum><text>if the source for such a standard for reimbursement is not publicly available, disclose to the applicable pharmacies and contracting entities of such pharmacies all individual drug prices to be so updated in advance of the use of such prices for the reimbursement of claims;</text>
</subparagraph><subparagraph commented="no" id="H0F22E6A2C0F946F5BB3846722DD87425" indent="up1"><enum>(D)</enum><text>establish a process to appeal, investigate, and resolve disputes regarding individual drug prices that are less than the pharmacy acquisition price for such drug, which must be adjudicated within 7 days of the pharmacy filing its appeal; and</text>
</subparagraph><subparagraph commented="no" id="H78507E5350D145C7B95C1CD6FDCD48E4" indent="up1"><enum>(E)</enum><text display-inline="yes-display-inline">provide all such pricing data in an .xml spreadsheet format or a comparable easily accessible and complete spreadsheet format.</text>
</subparagraph></paragraph><paragraph commented="no" id="HCD069E76B26C48A2B94F6C4A8E0CC745" indent="up1"><enum>(2)</enum><text>For purposes of paragraph (1), a standard for reimbursement of a pharmacy is any methodology or formula for varying the pricing of a drug or drugs during the term of the pharmacy reimbursement contract that is based on the cost of the drug involved, including drug pricing references and amounts that are based upon average wholesale price, wholesale average cost, average manufacturer price, average sales price, maximum allowable cost, or other costs, whether publicly available or not.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" id="HC516B4BC14AC455C9C01FF9A2FF1AA3B"><enum>(B)</enum><header>Application</header><text display-inline="yes-display-inline">The amendment made by subparagraph (A) shall apply to any contract entered into under section 8902 of title 5, United States Code, on or after the date of enactment of this section.</text>
</subparagraph></paragraph></subsection></section><section id="HD901FAA7101B435180469C691E391559" section-type="subsequent-section"><enum>303.</enum><header>Sunset of limit on maximum rebate amount for single source drugs and innovator multiple source
drugs</header><text display-inline="no-display-inline">Section 1927(c)(2)(D) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(c)(2)(D)</external-xref>) is amended by inserting after <quote>December 31, 2009,</quote> the following: <quote>and before December 31, 2024,</quote>.</text>
</section><section id="H6DB9D6ADB9B8469DA6B2ECA9D32000D6"><enum>304.</enum><header>Regulation of manufacturer-sponsored copay contributions</header><text display-inline="no-display-inline">Notwithstanding any other provision of law, the Secretary of Health and Human Services may establish a mechanism prohibiting drug manufacturers from contributing financially to patient copays, and establish a system of penalizing such behavior.</text>
</section><enum>IV</enum><header>PATENT DISCLOSURE REQUIREMENTS</header>
<section id="HD9D25450C5DB4F0F8CC6E893DBFE53C9"><enum>401.</enum><header>Patent disclosure and transparency requirements</header>
<subsection id="HD7C607C8DD844F30AD9C48B474A35A83"><enum>(a)</enum><header>In general</header>
<paragraph id="HF0F84E783B0D4FD0980CDCBDDDF5D01D"><enum>(1)</enum><header>In general</header><text>Section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H695B3081E9A747028E3DDB1803C7C9C5" style="OLC">
<subsection id="HAE2E0C9A4A8C47F599437ADDA626F29E"><enum>(o)</enum><header>Additional requirements with respect to patents</header>
<paragraph id="H2153DF43ABFE44F0A9ACB95D8A4EC5D0"><enum>(1)</enum><header>Publication of information</header>
<subparagraph id="HBBF624927D5D49299B91C08F76D9B4B0"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Within 1 year of the date of enactment of the <short-title>Biologic Patent Transparency Act</short-title>, the Secretary shall publish and make available to the public a single, easily searchable list that includes—</text>
<clause id="H9435EF07FCCE453B8010D327F6B1AF18"><enum>(i)</enum><text display-inline="yes-display-inline">the proper and proprietary name of each biological product licensed or deemed to be licensed under subsection (a) or (k);</text>
</clause><clause id="H5AC9653FCDC347999A70C438691D1E90"><enum>(ii)</enum><text display-inline="yes-display-inline">the date of approval and application number for each such biological product;</text> </clause><clause id="H2B0878B04782471D925B0F5BB4868C58"><enum>(iii)</enum><text>the marketing status, dosage form, route of administration, strength, and, if applicable, reference product, for each such biological product;</text>
</clause><clause id="H0168A87615BC4928AE3E69C4D86EDCB8"><enum>(iv)</enum><text>the licensure status for each such biological product, including whether the license at the time of listing is approved, withdrawn, or revoked;</text>
</clause><clause commented="no" id="H9ACF80D85592469198F2E8C59105A492"><enum>(v)</enum><text display-inline="yes-display-inline">for each such biological product that is a reference product for which an exclusivity period applies, and for which the Secretary has determined the dates of such exclusivity period, under subsection (k)(7)(A) or subsection (k)(7)(B) of this section or under section 527 of the Federal Food, Drug, and Cosmetic Act, including any extension of such exclusivity period in accordance with subsection (m) of this section, the date on which such exclusivity period expires;</text>
</clause><clause id="HF9301FD6D80D4A67B2C633B3C9290B0A"><enum>(vi)</enum><text>any determination of biosimilarity or interchangeability for each such biological product; and</text> </clause><clause id="H2C52A1604E1F4D19A5D222201CEFBB17"><enum>(vii)</enum><text>information regarding approved indications for each such biological product, in such manner as the Secretary determines appropriate.</text>
</clause></subparagraph><subparagraph id="H20C7D0F7FF7B4CA7AF1FEC0D4E69CA46"><enum>(B)</enum><header>Updates</header><text display-inline="yes-display-inline">Every 30 days after the publication of the first list under subparagraph (A), the Secretary shall revise the list to include—</text>
<clause id="H5CE5F82459E54ADE9EEE365C71545F51"><enum>(i)</enum>
<subclause commented="no" display-inline="yes-display-inline" id="H42D422679C704879906E03AA02DEF5C8"><enum>(I)</enum><text display-inline="yes-display-inline">each biological product licensed under subsection (a) or (k) during the 30-day period; and</text> </subclause><subclause id="H2B3D35041A8B4CCE8E45E3EA3322A75D" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">with respect to each biological product described in subclause (I), the information described in clauses (i) through (vii) of subparagraph (A); and</text>
</subclause></clause><clause id="HCC3AA1333EC24B5DA418D38353B3F9B0"><enum>(ii)</enum><text>any updates to information previously published in accordance with subparagraph (A).</text> </clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" id="H98DA27D1CDD1409FA7B334CD29EA3CBE"><enum>(2)</enum><header>Public listing of patent information</header> <subparagraph commented="no" id="HFED9647E0E6E479389C879E0E06373EB"><enum>(A)</enum><header>In general</header><text>The Secretary of Health and Human Services shall include in the recommendations transmitted to Congress under section 744I(f) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-53">21 U.S.C. 379j–53(f)</external-xref>) recommendations with respect to the collection and publication of patent information in the list described in section 351(o) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>), as added by paragraph (1).</text>
</subparagraph><subparagraph commented="no" id="H8117DC1805EB46BCA421CDE13F22C133"><enum>(B)</enum><header>Development</header><text>In developing recommendations under subparagraph (A), the Secretary of Health and Human Services may consult with the Federal Trade Commission, the Director of the United States Patent and Trademark Office, and the Federal Trade Commission, in addition to the entities listed in section 744I(f)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-53">21 U.S.C. 379j–53(f)(1)</external-xref>).</text>
</subparagraph></paragraph></subsection><subsection id="H3E5EB6F801FB47A0B59322DCA02A33E0"><enum>(b)</enum><header>Rule of construction</header><text>Nothing in this section, including the amendment made by this section, shall be construed to require or allow the Secretary of Health and Human Services to delay the review or approval of a biologic license application under section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>).</text>
</subsection></section><section id="H48C8D872E6644E9E9525CF21C7B1317A"><enum>402.</enum><header>Antitrust exemption for health insurance issuers To negotiate wholesale acquisition prices of
prescription drugs purchased from drug manufacturers</header>
<subsection id="H53032C53E89F4E19BE8972ECE8AE3C85"><enum>(a)</enum><header>Exemption</header><text display-inline="yes-display-inline">It shall not be a violation of the antitrust laws for one or more health insurance issuers or their designated agents to jointly negotiate wholesale acquisition prices of a prescription drug with a manufacturer of a prescription drug with regards to the reimbursement policies of the insurers of the manufacturer’s drugs so long as no single wholesale acquisition price is jointly determined between the insurance issuers or their designated agents.</text>
</subsection><subsection id="HDD2C710701314EB79E10BFA15057D942"><enum>(b)</enum><header>Definitions</header><text>For purposes of this section:</text> <paragraph id="HB74D491C37EA43C1BA0D73FD80BD49E7"><enum>(1)</enum><header>Antitrust laws</header><text>The term <term>antitrust laws</term> has the meaning given it in subsection (a) of the 1st section of the Clayton Act (<external-xref legal-doc="usc" parsable-cite="usc/15/12">15 U.S.C. 12(a)</external-xref>), except that such term includes section 5 of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45</external-xref>) to the extent such section 5 applies to unfair methods of competition.</text>
</paragraph><paragraph id="H65C89DCB85FB443FBBCD830508232DDC"><enum>(2)</enum><header>Health insurance issuer</header><text display-inline="yes-display-inline">The term <term>health insurance issuer</term> has the meaning given that term in section 2791(b) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-91">42 U.S.C. 300gg–91(b)</external-xref>).</text>
</paragraph><paragraph id="HEB9DF3BC1189432BBB219BAF51BCEF62"><enum>(3)</enum><header>Health maintenance organization</header><text>The term <term>health maintenance organization</term> means—</text> <subparagraph id="HD46D6929D4EB458A9DF7BFF6D70EBBB1"><enum>(A)</enum><text>a federally qualified health maintenance organization (as defined in section 300e(a) of title 42 of the Code of Federal Regulations),</text>
</subparagraph><subparagraph id="H649E93FB23DD48C6975D4D0CCC1114DD"><enum>(B)</enum><text>an organization recognized under State law as a health maintenance organization, or</text> </subparagraph><subparagraph id="H0D7777448A6B40D8B8F216DA957B6B01"><enum>(C)</enum><text>a similar organization regulated under State law for solvency in the same manner and to the same extent as such a health maintenance organization.</text>
</subparagraph></paragraph><paragraph id="HD2A55A01710247D8996E621C5C505E80"><enum>(4)</enum><header>Manufacturer</header><text>The term <term>manufacturer</term> means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug.</text>
</paragraph><paragraph id="H2403F88CBEA64BE3801A8F503F36A643"><enum>(5)</enum><header>Prescription drug</header><text>The term <term>prescription drug</term> means a drug for human use subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353(b)(1)</external-xref>).</text>
</paragraph></subsection><subsection id="H6206933ABC3143E5B68D009A1C080A41"><enum>(c)</enum><header>Effective date</header><text>This section shall take effect on the date of the enactment of this Act but shall not apply with respect to conduct that occurs before such date.</text>
</subsection></section><section id="HF13D8AA21E4D457F8C89DA0223F351F9"><enum>403.</enum><header>Fair treatment of Medicare part B billing codes for the prescribing of biosimilars</header><text display-inline="no-display-inline">Section 1847A of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-3a">42 U.S.C. 1395w–3a</external-xref>) is amended by adding at the end the following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="H4EF30DCAE4954C3C84B91B99C71A5D6E" style="OLC">
<subsection id="HD563F13B855E4146A16CE6386D68E586"><enum>(h)</enum><header>Use of certain codes</header><text display-inline="yes-display-inline">Notwithstanding any previous provision of this section, for purposes of payment of biological biosimilar product the Secretary of Health and Human Services shall assign a uniform Common Procedure System code to describe all such products that share a common reference product.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>V</enum><header>FIXING GLOBAL FREELOADING </header>
<section commented="no" id="H6FFAF6EEDBF946988F3C750156F5119D"><enum>501.</enum><header>Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative</header>
<subsection commented="no" id="H2EA1676FFFA34C90B8C4E73EDD139DF4"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 141 of the Trade Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/19/2171">19 U.S.C. 2171</external-xref>) is amended—</text> <paragraph commented="no" id="HDAED6445AFF6445D9A13D818D6D3CB9B"><enum>(1)</enum><text>in subsection (b)(2)—</text>
<subparagraph commented="no" id="H279AE41D9928471EB30A75089AFE49DE"><enum>(A)</enum><text>by striking <quote>and one Chief Innovation and Intellectual Property Negotiator</quote> and inserting <quote>one Chief Innovation and Intellectual Property Negotiator, and one Chief Pharmaceutical Negotiator</quote>;</text> </subparagraph><subparagraph commented="no" id="HAD0439DC98624E3B968086119983A881"><enum>(B)</enum><text>by striking <quote>or the Chief Innovation and Intellectual Property Negotiator</quote> and inserting <quote>the Chief Innovation and Intellectual Property Negotiator, or the Chief Pharmaceutical Negotiator</quote>; and</text>
</subparagraph><subparagraph commented="no" id="H1FC84230E2F14ECDAFCA2F9E01D3B716"><enum>(C)</enum><text>by striking <quote>and the Chief Innovation and Intellectual Property Negotiator</quote> and inserting <quote>the Chief Innovation and Intellectual Property Negotiator, and the Chief Pharmaceutical Negotiator</quote>; and</text> </subparagraph></paragraph><paragraph commented="no" id="H04F82CCD223940C39130A134D4B77CAA"><enum>(2)</enum><text>in subsection (c), by adding at the end the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="H4C5EC1CC23BC4960862085780043797F" style="OLC">
<paragraph commented="no" id="HFF14094646BD495D99220645C7FE67DC"><enum>(7)</enum><text display-inline="yes-display-inline">The principal function of the Chief Pharmaceutical Negotiator shall be to conduct trade negotiations and to enforce trade agreements relating to United States pharmaceutical products and services. The Chief Pharmaceutical Negotiator shall be a vigorous advocate on behalf of United States pharmaceutical interests, including patients and United States pharmaceutical workers. The Chief Pharmaceutical Negotiator shall perform such other functions as the United States Trade Representative may direct.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" id="HF5C74A25F1B043C7866C4C213DAC8DF4"><enum>(b)</enum><header>Compensation</header><text display-inline="yes-display-inline">Section 5314 of title 5, United States Code is amended by striking <quote>Chief Innovation and Intellectual Property Negotiator, Office of the United States Trade Representative.</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="HE7E39B0D39AF4A2CAA8C0B4F12CE4C9D" style="OLC">
<subsection commented="no" id="HFAD1226F68A64537A96BC02D056779F9"><enum></enum><text display-inline="yes-display-inline">Chief Innovation and Intellectual Property Negotiator, Office of the United States Trade Representative.</text>
</subsection><subsection commented="no" id="H4F254BE266A24FB2BD2D92BBE03329F6"><enum></enum><text display-inline="yes-display-inline">Chief Pharmaceutical Negotiator, Office of the United States Trade Representative.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" id="H5EBB5BBD06A34E65981B679E879B9F37"><enum>(c)</enum><header>Report required</header><text display-inline="yes-display-inline">Not later than one year after the appointment of the first Chief Pharmaceutical Negotiator pursuant to paragraph (2) of section 141(b) of the Trade Act of 1974, as amended by subsection (a), and annually thereafter, the United States Trade Representative shall submit to the Committee on Finance of the Senate and the Committee on Ways and Means of the House of Representatives a report describing in detail—</text>
<paragraph commented="no" id="HD27280323939451493DBC5AAB4726A0A"><enum>(1)</enum><text display-inline="yes-display-inline">enforcement actions taken by the Trade Representative during the one-year period preceding the submission of the report to ensure the protection of United States pharmaceutical products and services; and</text>
</paragraph><paragraph commented="no" id="HA8437DA8FE2F4F1781D8E5C834B027D2"><enum>(2)</enum><text display-inline="yes-display-inline">other actions taken by the Trade Representative to advance United States pharmaceutical products and services.</text>
</paragraph></subsection></section>